BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK VISION CORONARY STENT SYSTEM

    MDR report key: 3182414 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03859
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. IT SHOULD BE NOTED THAT PERFORATION IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: BALANCE MIDDLEWEIGHT, GUIDE CATH: 6F, SHEATH: 7F. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SAPHENOUS VEIN GRAFT TO A POSTERIOR DESCENDING ARTERY. A 3.0 X 15 MM VISION STENT WAS DEPLOYED; HOWEVER, THE PROXIMAL PORTION OF THE STENT DID NOT FULLY OPPOSE TO THE VESSEL WALL. A NON-ABBOTT BALLOON CATHETER WAS USED TO POST-DILATE THE VISION STENT WHEN A PERFORATION OCCURRED IN THE VEIN GRAFT. A 3.0 X 15 MM UNKNOWN BALLOON WAS INFLATED AND THEN A 3.0 X 16 MM GRAFTMASTER WAS SUCCESSFULLY IMPLANTED TO SEAL THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282020 MULTI-LINK VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention